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Department of Data Management
The NCCHD promotes quality clinical research and clinical trials in maternal and child health. Data management and data quality assurance are integral parts of quality clinical research and trials, and the demand for such services has been increasing dramatically in recent years. To that end, the Division of Data Management was established in July 2014 and reorganized in February 2015 to provide data management services for studies conducted at the NCCHD.
Our department consists of the Director, two Deputy Directors and six divisions.
Functions and services
We specialize in data collected from clinical research. Each division provides the following services:
Division of Data Management for Clinical Research
Developing protocols for clinical studies is an important task for our division, and we review study protocols with the view to minimize potential errors in data collection in clinical research. We are also responsible for data management, including the generation of computerized data, constructing databases, and organizing datasets for statistical analysis.
Division of Biostatistics
We aim to provide statistical support for clinical researchers at the NCCHD. Working closely with clinicians, we evaluate the statistical aspects of a project's study design, including target populations, endpoint selection, sample size determination, and specification of analysis methods. We also evaluate study feasibility by intensively analyzing clinical data from daily practice. In addition, members of our division actively participate in the department's clinical research consultation services and advanced educational programs for clinical research.
Division of Data Science for Clinical Research
The NCCHD is currently conducting a national project to integrate medical information from a number of children's hospitals into a national database. Our division is responsible for maintaining the database and recruiting hospitals for this project. In addition, we utilize the database to further promote clinical research, through which we aim to improve medical care for children, including reducing side effects, determining the appropriate dosage of medicine, and eliminating unnecessary medical tests.
Division of Registration and Research for Childhood Cancer
Although childhood cancer is relatively rare in Japan, approximately 2,000 to 2,500 children are diagnosed with cancer each year. Survival rates have dramatically improved over the past several years, but still remain low for some cancer types. Furthermore, long-term health problems, known as late effects, may develop in childhood cancer survivors many years after treatment has ceased.
In order to better understand childhood cancer, the Division of Registration and Research for Childhood Cancer was founded to support various clinical trials and research in childhood solid tumors conducted in Japan. We support Japan's major childhood solid tumor study groups, including the Japan Neuroblastoma Study Group (JNBSG), the Japan Rhabdomyosarcoma Study Group (JRSG), the Japanese Pediatric Brain Tumor Consortium (JPBTC), the Japan Wilms Tumor Study Group (JWiTS), the Japanese Study Group for Pediatric Liver Tumor (JPLT) and the Japan Ewing Sarcoma Study Group (JESS).
We are committed to planning, developing, and conducting clinical trials with these study groups. Our activities consist of more than 40 collaborative research projects, including nationwide multicenter clinical trials and observational studies, and childhood cancer registration conducted by the Japanese Society of Pediatric Hematology and Oncology.
Division of Data Linkage
By linking existing clinical data, multi-center registry data, and public data, we aim to resolve clinical research questions.
Division of Data Analysis
We aim to analyze data to evaluate the effectiveness of intervention by minimizing potential bias for robust causal inference.